Key Responsibilities
- Serve as a technical expert in biologic drug product formulation (mAbs, ADCs, LNPS, toxins), independently designing, executing, and interpreting studies to enable First-in-Human (FIH) and early clinical studies.
- Investigate, develop, and optimize liquid and lyophilized formulation and drug product approaches; improve analytical methods/assays to accelerate timelines.
- Support formulation with literature review; contribute to scientific reports, presentations, and patents.
- Execute drug product processing and filling activities (hands-on operation of fillers, liquid handlers, lyophilizers).
- Independently design and conduct process development studies to characterize manufacturability and ensure scalable, reproducible processes.
- Conduct and interpret in-use stability and compatibility studies; evaluate compatibility with administration devices and diluents.
- Adjust experimental plans with project leads/stakeholders; meet lab timelines; document results in an electronic lab notebook.
Qualifications / Required/Preferred
- BS in Chemistry/Biochemistry/Biology/Chemical Engineering/Pharmaceutical Sciences (typically 7+ years relevant industry experience) or MS (typically 5+ years).
- Demonstrated biologic formulation development experience (liquid and/or lyophilized).
- Hands-on protein characterization/stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).
- Hands-on experience with processing/filling equipment (fillers, liquid handlers, lyophilizers).
- Experience with in-use stability and/or clinical compatibility studies preferred.
- Ability to independently design/execute/interpret critical experiments; troubleshoot; strong communication and scientific writing.
Benefits (as stated)
- Paid time off; medical/dental/vision insurance; 401(k); eligible for short-term incentive programs.